Indications
Esomeprazole is indicated:
- Treatment of Gastroesophageal Reflux Disease (GERD)
- Healing of Erosive Esophagitis
- Maintenance of Healing of Erosive Esophagitis
- Symptomatic Gastroesophageal Reflux Disease
- H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
- Zollinger-Ellison Syndrome
- Acid Related Dyspepsia
- Duodenal and Gastric Ulcer
Therapeutic Class
Pharmacology
Dosage
Tablet:
Healing of erosive esophagitis: 20 mg or 40 mg once daily for 4 to 8 Weeks. For those patients who have not healed after 4-8 weeks of treatment, an additional 4-8 weeks course of Esomeprazole may be considered.
Long-term management of esophagitis: 20 mg once daily.
Symptomatic gastroesophageal reflux disease: 20 mg once daily for 4 weeks.
H. pylori eradication for treatment of duodenal ulcer:Â Triple therapy: 20 mg Esomeprazole once daily with 500 mg Clarithromycin twice daily, and 1 g Amoxicillin twice daily for 7-10 days.
Injection:
The recommended adult dose in GERD with Erosive Esophagitis is either 20 or 40 mg Esomeprazole given once daily by intravenous injection (no less than 3 minutes) or intravenous infusion (10 to 30 minutes).
Pediatric dose (1 to 11 years old):
- Short term treatment of symptomatic GERD: 10 mg once daily for up to 8 weeks.
Healing of erosive esophagitis:
- Weight <20 kg: 10 mg once daily for up to 8 weeks.
- Weight ≥20 kg: 10 mg or 20 mg once daily for up to 8 weeks.
Administration
Preparations for Use and Administration of Esomeprazole 40 IV Injection: A solution for intravenous infusion is prepared by first reconstituting the contents of one vial with 5 ml of 0.9% Sodium Chloride and further diluting the resulting solution to a final volume of 50 ml. The resultant concentration after diluting to a final volume of 50 ml is 0.8 mg/ml.
- 20 mg dose: Withdraw 25 ml of the final solution and administer as an intravenous infusion over 10 minutes to 30 minutes.
- 10 mg dose: Withdraw 12.5 ml of the final solution and administer as an intravenous infusion over 10 minutes to 30 minutes.
Interaction
Contraindications
Side Effects
Pregnancy & Lactation
Pregnancy: There are no adequate and well-controlled studies on the use of Esomeprazole in pregnant women. Therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk. Esomeprazole should be used during pregnancy only if the potential benefit to pregnant women justifies the potential risk to the fetus.
Lactation: Esomeprazole is excreted in human milk. Thus, a decision should be taken to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Precautions
Overdose Effects
Use in Special Population
Geriatric: Dosage adjustment is not necessary.
Pediatric: Safety and effectiveness in pediatric patients have not been established.
Hepatic insufficiency: No dosage adjustment is recommended for patients with mild to moderate hepatic insufficiency. However, in patients with severe hepatic insufficiency a dose of 20 mg once daily should not be exceeded.
Renal insufficiency: Dosage adjustment is not necessary.
Reviews
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